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Developing Country Sales Continue to Drive Growth at Cepheid as China Approves Xpert TB Test

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NEW YORK (GenomeWeb) — Cepheid's high-burden developing country (HBDC) program — the initiative through which it sells its GeneXpert system and related tuberculosis/drug-resistance test to resource-poor territories at a subsidized, discounted price — continues to serve as an important revenue driver at the company.

The Sunnyvale, Calif.-based MDx firm said last week that its first quarter revenues grew 16 percent year over year to $106.9 million, driven in no small part by 69 percent growth in its HBDC program to $18.3 million.

And it doesn't appear as if the company's HBDC-related growth will taper anytime soon. During a conference call recapping Cepheid's earnings, CEO John Bishop disclosed that the firm received Chinese Food and Drug Administration clearance for its tuberculosis assay, Xpert MTB/RIF, late in the first quarter. Bishop also noted that the company has begun logging significant revenues from a previously announced national roll-out of GeneXpert and MTB/RIF in Brazil, where Cepheid placed 160 GeneXpert systems in Q1 — about half of the 322 total HBDC systems it placed in the quarter.

"We now have almost 2,300 systems and 104 HBDCs around the world, and yet we continue to be in the early stages of market adoption," Bishop said. "This is notably the case in India and China, which report the highest and second highest numbers of TB cases, respectively, through the World Health Organization."

With the CFDA clearance in pocket, Cepheid now expects to ship more than 700 GeneXpert systems — supported by the non-profit agency The Global Fund to Fight AIDS, Tuberculosis, and Malaria — to China during the second quarter.

"Combined with the 179 systems already placed in China, this will bring the HBDC installed base in that country to almost 900," Bishop said. "To put that in perspective, the HBDC installed base in South Africa at the end of the first quarter was 342."

Bishop warned investors, however, that with regards to new HBDC system placements, "these programs will take time to ramp, so please apply caution when considering reagent pull-through associated with both the first-quarter placements in Brazil and the expected second-quarter placements in China. That said, with more than 900,000 cases of TB reported to the WHO in 2012, we are proud to participate in what we believe will be a true game changer for TB diagnosis and treatment in China. We're also very excited to have this opportunity to introduce our GeneXpert system to the Chinese clinical community more broadly, which on a longer-term basis we believe offers a significant potential for our commercial operations."

Further underscoring the importance of the planned GeneXpert rollout in China, and the HBDC program in general, Bishop said during the call that the program has been creating many other opportunities besides tuberculosis testing in the HBDC markets.

"That’s one of the big advantages of our HBDC program," Bishop said. "It’s not only opened the doors but it’s thrown the doors wide open to getting us into markets that would have been much slower for us to get into at this point."

Bishop added that Cepheid is current preparing several other Xpert tests for CFDA filing, including assays for methicillin-resistant Staphylococcus aureus, influenza, and Clostridium difficile.

"I'm looking forward as we move into next year or so to ramp up and bring our virology products forward, because … if you go look at China right now and [identify the] most common molecular tests that are currently being done, it's more the viral products," Bishop said. "So this will give us a key introduction to China. It's going to give us a very nice head start. It's going to educate the community on the full benefits on the GeneXpert."

Cepheid's overall Q1 revenues of $106.9 million reflected a $15 million increase over the prior-year quarter, as growth in both commercial clinical and HBDC offset an almost $6 million decline in non-clinical revenues. Cepheid's clinical business, which includes commercial clinical and HBDC, grew 26 percent in Q1, and represented 94 percent of total company revenue. Clinical systems revenue grew 38 percent to $17.3 million from $12.5 million, while clinical reagents revenue spiked 24 percent to $83.1 million from $67.1 million. Meantime, non-clinical and other revenue were cut nearly in half to $6.5 million from $12.3 million.

Cepheid also updated its full-year 2014 guidance to total revenue in the range of $446 million to $461 million and a net loss in a range from $.43 to $.38 per share. In its Q4 and full-year 2013 earnings release in January the company had guided to a similar revenue range, but said it expected a range of $.26 to $.21 for its net loss per share.

"We continue to expect commercial clinical revenue in the range of $335 million to $346 million, growth of 14 percent to 18 percent from 2013," Cepheid CFO Andrew Miller said during last week's call. "Within commercial clinical, we continue to expect commercial clinical reagents to grow 15 percent to 20 percent, and commercial clinical systems to grow in the low-single digits. And we continue to expect HBDC revenue in the range of $84 million to $88 million and non-clinical revenue to be approximately $27 million."

Cepheid's full Q1 earnings and 2014 guidance are detailed here.

Bishop noted later during the call that Cepheid's full-year revenue guidance remained unchanged from earlier in the year because the company had factored in the expected large HBDC order in China in Q2.

Cepheid executives also noted during the conference call that the company recently commercialized its Xpert HPV and Xpert Norovirus assays

"Xpert HPV is of course a very exciting addition to our menu outside of the US, where the market is moving far more rapidly toward using HPV tests as the primary screen versus cytology," Bishop said. "Italy and Spain, for example, have already started using HPV testing as a primary screening test in certain regions. Scotland has already made the move to HPV primary screening and the Netherlands has committed to do so by 2016.

Xpert Norovirus, meanwhile, is "an important addition to our infectious disease portfolio for many of our European customers," Bishop said, adding that norovirus is highly contagious and can spread quickly, making an accurate molecular test a boon for diagnosing and stemming outbreaks.

"While the market is less developed in the US, this is an established market in Europe with approximately 1 million tests per year," Bishop said. "Currently, customers are forced to choose between fast but notoriously poor-performing [immunoassay] tests or accurate but slow molecular tests. With Xpert Norovirus, customers no longer have to sacrifice performance for speed. We believe that this will be a compelling add-on test for existing GeneXpert customers, as the largest markets are in geographies where we already have direct sales operations and sizable installed bases, notably Germany, the UK, Italy, and France."

The new tests also bring Cepheid's total Xpert assay tally to 14, a fact that Bishop said continues to help the company sell GeneXpert systems.

"GeneXpert system placements are increasingly driven by broad menu adoption, so while we continue to add new HAI customers and test volumes continue to grow, we more often see our HAI tests placed with one or more non-HAI assays," Bishop said.

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